Interferon beta containing medicines are currently used to treat patients with multiple sclerosis. r-FSH is a hormone that stimulates the growth and recruitment of immature ovarian follicles in the ovary. It is therefore used to help infertile couples to conceive.

The guidelines lay down the non-clinical and clinical requirements for biosimilars containing interferon beta or r-FSH and claiming to be similar to a biological that is already marketed. The non-clinical sections address the pharmacotoxicological requirements and the clinical sections describe the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.

Guideline on similar biological medicinal products containing interferon beta
EMA/CHMP/BMWP/652000/2010
Effective date: 1 September 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139622.pdf

Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)
EMA/CHMP/BMWP/671292/2010
Effective date: 1 September 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139624.pdf

The draft guidelines for interferon beta and r-FSH were published for a six-month consultation period in November and December 2011, respectively. Comments on the interferon beta guideline were received from Bayer Pharma, the Dutch Medicines Evaluation Board (CBG-MEB), European Biopharmaceutical Enterprises and Synthon. Comments on the r-FSH guideline were received from the European Generics medicines Association and Ferring Pharmaceuticals. Comments on the draft guidelines were taken into account by EMA in producing the final guidelines.

Both guidelines were published by EMA on 21 February 2013 and will come into effect on 1 September 2013.

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EU guidelines for biosimilars

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